Moore ex rel. Frazier v. Mylan Inc.
840 F. Supp. 2d 1337
N.D. Ga.2012Background
- Phenytoin (Dilantin) products allegedly caused decedent’s severe adverse skin reactions leading to death.
- Plaintiffs include surviving spouse Johnnie May Frazier (representing estate and individuals), decedent’s son George L. Frazier, Jr., son Jonathan A. Frazier, widow Tanya Cephus, and the estate.
- Defendants are Mylan (generic phenytoin) and Pfizer (brand Dilantin) involved in testing, manufacturing, packaging, labeling, and distributing phenytoin.
- Action filed in state court, removed to federal court on diversity grounds; complaint asserts strict liability, fraud, negligence, gross negligence, wrongful death, and punitive damages.
- Plaintiff alleges decedent was prescribed and ingested phenytoin; adverse reactions include TEN/SJS; death occurred January 23, 2009.
- Court addresses motions to dismiss under Fed. R. Civ. P. 12(b)(6).
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Standing of the plaintiffs to sue for wrongful death | Multiple plaintiffs seek standing. | Only surviving spouse has standing to pursue wrongful death claims. | Only Johnnie May Frazier has standing; others lack standing. |
| Strict product liability—failure to warn against Pfizer | Pfizer owed duty to warn decedent and physicians directly. | Learned intermediary doctrine limits duty to warn to physicians; patient/public warnings barred. | Limited to warning of decedent’s prescribing physician; others dismissed. |
| Strict product liability—defective design/manufacture against all defendants | Phenytoin products defective in design or manufacture; feasible safer designs exist. | Plaintiff failed to plead specific design/manufacturing defect or causation; lacks factual allegations. | Dismissed for lack of specific defect and causal linkage; leave to amend granted. |
| Fraud against Pfizer | Pfizer misrepresented and concealed safety information about phenytoin. | Fraud claim not pled with particularity under Rule 9(b). | Fraud claim dismissed for lack of particularity; leave to amend denied or limited. |
| Negligence and gross negligence; preemption issues | Pfizer and Mylan breached duties; gross negligence alleged. | Some claims preempted by Mensing; uncertainties about who caused injury. | Claims insufficiently pled; preemption partially bars certain claims; leave to amend may be allowed. |
Key Cases Cited
- Bell Atlantic Corp. v. Twombly, 550 U.S. 544 (U.S. 2007) (plaintiffs must plead plausible claims, not mere allegations)
- Ashcroft v. Iqbal, 556 U.S. 662 (U.S. 2009) (plausibility standard for pleading claims)
- Mensing v. Novo Nordisk, Inc., 131 S. Ct. 2567 (U.S. 2011) (federal preemption of some state failure-to-warn claims for generics)
- Ziemba v. Cascade Int’l, Inc., 256 F.3d 1194 (11th Cir. 2001) (rules for pleading fraud with particularity under Rule 9(b))